Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126209011 | 12620901 | 1 | I | 20131026 | 20160804 | 20160804 | EXP | NL-CIPLA LTD.-2016NL10049 | CIPLA | FILLEKES Q, MURO EP, CHUNDA C, AITKEN S, KISANGA ER, KANKASA C, ET AL. EFFECT OF 7 DAYS OF PHENYTOIN ON THE PHARMACOKINETICS OF AND THE DEVELOPMENT OF RESISTANCE TO SINGLE-DOSE NEVIRAPINE FOR PERINATAL HIV PREVENTION: A RANDOMIZED PILOT TRIAL. JOURNAL OF ANTIMICROBIAL CHEMOTHERAPY. 2013;68:2609 TO 2615 | 0.00 | Y | 0.00000 | 20160804 | OT | NL | NL |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 126209011 | 12620901 | 1 | PS | NEVIRAPINE. | NEVIRAPINE | 1 | Unknown | 200 MG, SINGLE-DOSE DURING ONSET OF LABOUR | 77956 | 200 | MG | ||||||||
| 126209011 | 12620901 | 2 | SS | ZIDOVUDINE. | ZIDOVUDINE | 1 | Unknown | 300 MG, BID, FROM 28 AND 14 WEEKS OF GESTATION | U | U | 0 | 300 | MG | BID | |||||
| 126209011 | 12620901 | 3 | SS | ZIDOVUDINE. | ZIDOVUDINE | 1 | Oral | UNK, AT THE ONSET OF LABOUR | U | U | 0 | ||||||||
| 126209011 | 12620901 | 4 | SS | ZIDOVUDINE. | ZIDOVUDINE | 1 | Unknown | 300 MG, BID, POST DELIVERY, FOR 7 DAYS | U | U | 0 | 300 | MG | BID | |||||
| 126209011 | 12620901 | 5 | SS | LAMIVUDINE. | LAMIVUDINE | 1 | Unknown | UNK, EVERY 12 HOURS UNTIL DELIVERY | U | U | 0 | ||||||||
| 126209011 | 12620901 | 6 | SS | LAMIVUDINE. | LAMIVUDINE | 1 | Unknown | 150 MG, BID, POST DELIVERY | U | U | 0 | 150 | MG | BID | |||||
| 126209011 | 12620901 | 7 | SS | PHENYTOIN. | PHENYTOIN | 1 | Unknown | 184 MG, QD, FROM THE ONSET OF LABOUR FOR 7 DAYS | U | U | 0 | 184 | MG | QD |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 126209011 | 12620901 | 1 | Prophylaxis against HIV infection |
| 126209011 | 12620901 | 2 | Prophylaxis against HIV infection |
| 126209011 | 12620901 | 5 | Prophylaxis against HIV infection |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 126209011 | 12620901 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 126209011 | 12620901 | Adverse event | |
| 126209011 | 12620901 | Exposure during pregnancy |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| no results found |